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Predictors of Periodontal Outcomes Post-sanative Therapy

15 de noviembre de 2021 actualizado por: Wendy E. Ward, Ph.D., Brock University

Predictors of Periodontal Outcomes in Patients 5 to 10 Years Post-sanative Therapy

Periodontal disease is a chronic inflammatory disease of the tissues surrounding the teeth and is one of the leading causes of tooth loss. Sanative therapy (ST) is a non-surgical procedure that allows for removal of bacteria from the deep pockets that form around teeth and is the frontline treatment for periodontal disease. Post-ST, patients require ongoing maintenance appointments to maintain their oral health, though whether risk factors for periodontal disease remain a predictor of periodontal health post-ST has not been comprehensively investigated. Risk factors to be examined include physical activity, exercise, sedentary time, flavonoid intake, protein intake, BMI, sex, age, smoking status, and number of sites with periodontal probing depth (PPD) ≥ 4mm at baseline.

Descripción general del estudio

Estado

Terminado

Descripción detallada

Periodontal disease is a main cause of tooth loss. Patients with periodontal disease may receive sanative therapy (ST), a deep cleaning of the teeth that helps prevent the progression of periodontal disease. Post-ST, maintenance appointments are an important part of the strategy used to help these patients prevent the progression of periodontal disease and maintain their periodontal health. Given that numerous chronic diseases, obesity, low levels of physical activity, being a smoker, poor diet, and older age are all risk factors for periodontal disease, these factors may also be predictive of worse periodontal health 5 to 10 years post-ST. Many modifiable periodontal risk factors such a physical activity, exercise, and obesity have not been studied in relation to periodontal outcomes post-ST, and other factors such as diet, sex and age have not been comprehensively studied. The primary objective of this study is to determine, at 5 to 10 years post-ST, if physical activity, exercise, sedentary time, flavonoid intake, protein intake, BMI, sex, age, smoking status, and number of sites with periodontal probing depth (PPD) ≥ 4 mm at baseline are significant predictors of periodontal health. A secondary objective is to determine if lifetime estrogen exposure impacts periodontal health in women. Periodontal health will be measured using probing depth, tooth loss, bleeding on probing and plaque index. Established questionnaires will be used to assess dietary intake, physical activity and sedentary behaviour. Within the study the investigators will also assess if and how a patient's periodontal health has been impacted by clinic closures and rescheduling of maintenance appointments that were mandated by regulatory organizations as a result of the COVID-19 pandemic. The investigators will also ask questions about changes in diet, physical activity and oral hygiene during COVID-19.

Tipo de estudio

De observación

Inscripción (Actual)

12

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Ontario
      • Fonthill, Ontario, Canadá, L0S1E5
        • Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
      • St. Catharines, Ontario, Canadá, L2S3A1
        • Brock University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

19 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

Adult patients who underwent sanative therapy to manage periodontal disease at this clinic 5 to 10 years before present-day appointment. Only patients who have maintained regular maintenance appointments after receiving sanative therapy will be eligible.

Descripción

Inclusion Criteria:

  • Have undergone sanative therapy (ST) in the past 5 to 10 years
  • Age > 19 years
  • Willingness and ability to provide informed consent. Participants must be able and willing to complete online questionnaires from home and give permission for access to their periodontal records from the time of their sanative therapy to present day

Exclusion Criteria:

  • Individuals with physical or mental limitations that inhibit them from conducting their own personal oral hygiene (oral hygiene is a key component in maintaining periodontal health)
  • Women who are currently pregnant or breastfeeding (hormonal changes during pregnancy are known to cause gingival inflammation)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Probing depth
Periodo de tiempo: At maintenance appointment (present day)
This is a routine clinical measure of periodontal health (measured in mm)
At maintenance appointment (present day)
Probing depth
Periodo de tiempo: Pre-sanative therapy
This is a routine clinical measure of periodontal health (measured in mm)
Pre-sanative therapy
Probing depth
Periodo de tiempo: 8-12 weeks post-sanative therapy
This is a routine clinical measure of periodontal health (measured in mm)
8-12 weeks post-sanative therapy
Bleeding on probing
Periodo de tiempo: At maintenance appointment (present day) and retrospectively from the clinical record from the time of sanative therapy (5 to 10 years ago) onwards
This is a clinical measure of inflammation and represented as the percent of bleeding sites that are measured at 6 sites per tooth
At maintenance appointment (present day) and retrospectively from the clinical record from the time of sanative therapy (5 to 10 years ago) onwards
Bleeding on probing
Periodo de tiempo: Pre-sanative therapy
This is a clinical measure of inflammation and represented as the percent of bleeding sites that are measured at 6 sites per tooth
Pre-sanative therapy
Bleeding on probing
Periodo de tiempo: 8-12 weeks post-sanative therapy
This is a clinical measure of inflammation and represented as the percent of bleeding sites that are measured at 6 sites per tooth
8-12 weeks post-sanative therapy

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Tooth Loss
Periodo de tiempo: At maintenance appointment (present day) and retrospectively from the clinical record from the time of sanative therapy (5 to 10 years ago) onwards
Will be measured as the number of teeth lost due to periodontal disease
At maintenance appointment (present day) and retrospectively from the clinical record from the time of sanative therapy (5 to 10 years ago) onwards
Tooth Loss
Periodo de tiempo: Pre-sanative therapy
Will be measured as the number of teeth lost due to periodontal disease
Pre-sanative therapy
Tooth Loss
Periodo de tiempo: 8-12 weeks post-sanative therapy
Will be measured as the number of teeth lost due to periodontal disease
8-12 weeks post-sanative therapy
O'Leary Index of Plaque Control
Periodo de tiempo: At maintenance appointment (present day) and retrospectively from the clinical record from the time of sanative therapy (5 to 10 years ago) onwards
The patient's plaque index= the number of plaque-containing surfaces divided by the total number of available surfaces. The minimum plaque index would be 0% which represents no tooth surfaces that contain plaque/ The maximum plaque index would be 100%, which represents all surfaces of the patient's teeth containing plaque.
At maintenance appointment (present day) and retrospectively from the clinical record from the time of sanative therapy (5 to 10 years ago) onwards
Índice de O'Leary de control de la placa
Periodo de tiempo: Terapia pre-sanativa
El índice de placa del paciente = el número de superficies que contienen placa dividido por el número total de superficies disponibles. El índice de placa mínimo sería del 0 %, lo que representa que no hay superficies dentales que contengan placa. El índice de placa máximo sería del 100 %, lo que representa todas las superficies de los dientes del paciente que contienen placa.
Terapia pre-sanativa
Índice de O'Leary de control de la placa
Periodo de tiempo: 8-12 semanas después de la terapia sanativa
El índice de placa del paciente = el número de superficies que contienen placa dividido por el número total de superficies disponibles. El índice de placa mínimo sería del 0 %, lo que representa que no hay superficies dentales que contengan placa. El índice de placa máximo sería del 100 %, lo que representa todas las superficies de los dientes del paciente que contienen placa.
8-12 semanas después de la terapia sanativa

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Body Mass Index (BMI)
Periodo de tiempo: Patients will complete this in an online questionnaire at present day (baseline).
Patients will self-report their height and weight in an online questionnaire. This information will be used to calculate BMI which is a known risk factor of periodontal disease.
Patients will complete this in an online questionnaire at present day (baseline).
Godin Leisure Time Exercise Questionnaire
Periodo de tiempo: Patients will complete this in an online questionnaire at present day (baseline).

This questionnaire measures, at one time point, self-reported exercise habits for the past 7 days. This questionnaire includes 4 items and has been combined with the International Physical Activity Questionnaire.

Name of score: Weekly leisure activity score; Minimum score: 0 units and Maximum score: 24 units or more and defined as "active". A higher score indicates a better outcome.

Patients will complete this in an online questionnaire at present day (baseline).
International Physical Activity Questionnaire (IPAQ)
Periodo de tiempo: Patients will complete this online questionnaire at present day (baseline).

This questionnaire measures, at one time point, self-reported physical activity and sedentary behavior habits. It contains 27 items and has been combined with the Godin Leisure Time Exercise Questionnaire and modified version of the indices of estrogen exposure questionnaire in an online format. They will self-report their physical activity and sedentary behavior for the past 7 days.

Name of score: Weekly physical activity score; Minimum score: 1 and defined as "low physical activity" and Maximumscore: 3 and defined as "high physical activity". A higher score indicates a better outcome.

Patients will complete this online questionnaire at present day (baseline).
Flavonoid and protein intake
Periodo de tiempo: Patients will report their dietary intake at present day (baseline) for the past 24 hours. This will be done three times for three separate dates.
Flavonoid and protein intake will be measured with the automated self-administered dietary intake (ASA-24) questionnaire. This is an online food recall that patients will complete three times, reporting on their dietary intake from the last 24 hours.
Patients will report their dietary intake at present day (baseline) for the past 24 hours. This will be done three times for three separate dates.
Lifetime estrogen exposure (LEE)
Periodo de tiempo: Patients will complete this online questionnaire at present day (baseline).
The indices of estrogen exposure questionnaire will be used to determine LEE using the estimated lifetime estrogen exposure (ELEE) model. The ELEE reflects the reproductive span, comprising a woman's time between age at menarche and age at menopause (or age at recruitment minus age at menarche for pre-menopausal women) minus 1 year for each pregnancy and duration of breastfeeding, calculated at the time at recruitment.
Patients will complete this online questionnaire at present day (baseline).
Dietary supplement and tea intake
Periodo de tiempo: Patients will complete this questionnaire online prior to their maintenance appointment
Intakes of specific dietary supplements and tea will be measured using a dietary supplement and tea intake questionnaire.
Patients will complete this questionnaire online prior to their maintenance appointment
COVID-19 Interview questions
Periodo de tiempo: Patients will complete these interview questions during their one-on-one virtual meeting with a member of the research team at present day (baseline).
Patients will be asked interview questions about changes to their dietary intake, physical activity and oral hygiene habits resulting from the COVID-19 pandemic
Patients will complete these interview questions during their one-on-one virtual meeting with a member of the research team at present day (baseline).

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Wendy E Ward, PhD, Brock University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

25 de noviembre de 2020

Finalización primaria (Actual)

20 de octubre de 2021

Finalización del estudio (Actual)

20 de octubre de 2021

Fechas de registro del estudio

Enviado por primera vez

9 de noviembre de 2020

Primero enviado que cumplió con los criterios de control de calidad

17 de noviembre de 2020

Publicado por primera vez (Actual)

20 de noviembre de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de noviembre de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

15 de noviembre de 2021

Última verificación

1 de noviembre de 2021

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

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INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Enfermedades periodontales

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